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New drug gives hope to heart failure sufferers

Rory Callinan

Novartis executives say the company will file for approval of the drug, known by the code name LCZ696, in the US by the end of the year. Photo: Peter Rae

A newly developed drug could significantly improve the treatment of heart failure – a condition that is diagnosed in an estimated 30,000 Australians every year.

So far known only by the code name LCZ696, the drug has shown a striking efficacy in prolonging lives and could replace what has been the bedrock treatment for more than 20 years, researchers said Saturday.

Developed by the Swiss company Novartis, in a large clinical trial it reduced both the risk of dying from cardiovascular conditions and the risk of being hospitalised for worsening heart failure by about 20 per cent.

"I think that when physicians see these data, they will find [them] compelling, and what we will see is a paradigm shift," said Dr Milton Packer, a professor of clinical sciences at the University of Texas Southwestern Medical Centre in Dallas and one of the two principal investigators in the study, which was funded by Novartis.

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The results were being presented at the European Society of Cardiology congress in Barcelona, Spain, at the weekend and were published on Saturday by The New England Journal of Medicine.

Heart failure is a disease in which the heart cannot pump enough blood to the body's organs, resulting in shortness of breath, fatigue and retention of fluids. The Heart Foundation estimates some 30,000 Australians are diagnosed with the debilitating condition every year and recurrent hospitalisations cost the national economy more than $1 billion each year.

Some doctors not involved in the study agreed that the results were compelling.

On Sunday, Sydney cardiologist Dr Maros Elsik described the results as a "promising breakthrough".

"Certainly everyone is excited about it, and if the findings are translated to a real-life population of heart failure patients it could have a tremendous impact on the reduction of morbidity and mortality of those affected," said Dr Elsik who is based at Concord Hospital in Sydney.

He said there had not been a major breakthrough in the pharmaceutical treatment of heart failure for probably a decade. "There's constant research in this area and the treatments we have had available to us today have expanded over time, and we have been adding to established and proven treatments," he said.

"But this new drug basically beats one of the older established drugs that we have been using for a long time."

Dr Elsik said the time frame for such a drug to become available in somewhere like Australia could take anything from months to years, depending on how long it takes to be approved by Australian regulators.

Novartis executives say the company will file for approval of LCZ696, in the US by the end of the year and in Europe in the first quarter of next year. That means the drug could get to patients as early as next year.

The study involved more than 8400 patients in 47 countries who were randomised to receive either LCZ696 or enalapril, one of a class of drugs called ACE inhibitors that have been the standard treatment for heart failure. Most patients also used beta blockers and other drugs, as their doctors saw fit.

The patients were followed for a median of 27 months. By that point, 21.8 percent of those who received LCZ696 had died from a cardiovascular cause or had been hospitalised for worsening heart failure.

That figure was 26.5 per cent for those receiving enalapril. That represents a 20 per cent relative reduction in risk using a statistical measure called the hazard ratio.

The reductions in risk for both cardiovascular death alone and hospitalisation alone were also about 20 per cent. About 32 patients had to be treated with LCZ696 to prevent one death from cardiovascular causes.

LCZ696 was relatively well tolerated, though patients who clearly could not tolerate the specified doses of either LCZ696 or enalapril were eliminated from the trial in advance.

LCZ696 caused more hypotension, or too-low blood pressure, but fewer kidney problems than enalapril. LCZ696 is a combination of two drugs. One is valsartan, the blockbuster heart drug that Novartis sells as Diovan. The other component inhibits the enzyme neprilysin, a new mechanism for a heart failure drug.